title: The precision study: examining the inter- and intra-assay variability of replicate measurements of BGStar, iBGStar and 12 other blood glucose monitors.
abstract: OBJECTIVE
  Self-monitoring of blood glucose is a key element in diabetes management. Accurate and precise performance of blood glucose monitors (BGMs) ensures that valid values are obtained to guide treatment decisions by patients and physicians. BGStar and iBGStar are hand-held BGMs that use dynamic electrochemistry to correct for potential interferences and thereby minimize system errors.
  
  
  METHODS
  A single-center, in vitro diagnostic device performance evaluation with heparinized oxygenated venous blood samples (intra-assay precision) and control solutions (interassay precision) was performed in a laboratory setting, comparing BGStar and iBGStar with 12 competitors.
  
  
  METHODS
  The primary outcome was the coefficient of variation percent (CV%) of the BGMs investigated.
  
  
  RESULTS
  In inter-assay precision analyses, all but GlucoMen LX had a CV <5%, and in intra-assay precision analyses, 10 of the 14 devices tested had CV <5%. BGStar and iBGStar had a CV <5% in both the inter- and intra-assay precision analyses. The smallest variation was found in the near-normoglycemic glucose range (5.3 - 8.0 mmol/l) for both BGStar and iBGStar in the inter-assay precision analysis.
  
  
  CONCLUSIONS
  BGStar and iBGStar were proven to have very good inter-assay and high intra-assay precision, demonstrating low scattering of replicate measurements with both clinical samples and control solutions.
authors.affiliation: IKFE - Institute for Clinical Research and Development , Parcusstr. 8, D-55116 Mainz , Germany +49 6131 5763610 +49 6131 5763611 AndreasP@IKFE.de.
authors.forename: Sanja
authors.initials: S
authors.lastname: Ramljak
authors.forename: Petra B
authors.initials: PB
authors.lastname: Musholt
authors.forename: Christina
authors.initials: C
authors.lastname: Schipper
authors.forename: Frank
authors.initials: F
authors.lastname: Flacke
authors.forename: Jochen
authors.initials: J
authors.lastname: Sieber
authors.forename: Marcus
authors.initials: M
authors.lastname: Borchert
authors.forename: Thomas
authors.initials: T
authors.lastname: Forst
authors.forename: Andreas
authors.initials: A
authors.lastname: Pfützner
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation*; D003920:Diabetes Mellitus / Q000097:blood*; D006801:Humans; D008875:Middle Aged; D015203:Reproducibility of Results; D055815:Young Adult
chemical_list: D001786:Blood Glucose